This invention relates to a xe2x80x9cone devicexe2x80x9d system and method for collecting, extracting, testing, and confirming various constituents in fluids. In particular, this system is suitable for detecting drugs of abuse in bodily fluids. In one embodiment, the system is used to collect a human""s saliva, sweat, urine, blood or other bodily fluid sample to test and/or confirm for drugs of abuse. In a preferred embodiment, the bodily fluid is collected via a collection end of the device with an absorbent pad, a series of pressure heads inside the cap of the collection device forces the sample (as the collection end of the device passes through the pressure heads) into the core of an immunoassay system containing diagnostic strips for drug of abuse detection. The drug in the sample competes with a drug conjugate immobilized on a membrane support for limited antibody sites on colored micro-spheres. A colored line indicates the presence or absence of illegal drugs in the sample. Furthermore, a portion of the sample is retained in a confirmation sample retention well, which is seal from the outside allowing samples stored for further testing.
A number of devices and methods are commonly available to collect, extract, or test for various constituents in fluids. However, these devices require separate collection, extraction and testing of the sample. This device is designed to combine these three key functions into one device. Generally, fluids include saliva, urine, blood, sweat or other bodily fluids. The constituents include the detection for the presence of drugs of abuse, toxins, alcohols, glucose, cholesterol, urea, antigen or antibody, etc.
U.S. Pat. No. 4,431,742 to Rosenblatt describes a radio-receptor assay for benzodiazpines in saliva which comprises measuring the diminution of attachment of a know quantity of radio labeled benzodiazepine to a receptor carrier in the presence of an unknown quantity of unlabeled benzodiazepine in a known amount of human saliva.
U.S. Pat. Nos. 5,339,829, 5,479,937, 5,573,009, and 5,830,410 to Thieme et al describe a device for obtaining oral fluid containing substances for testing that includes a syringe having a plunger at the end of which an absorbent pad is attached.
U. S. Pat. No. 5,714,341 to Thieme et al describes an improved method for determining the presence of an analyte in an oral fluid sample. A portion of the sample is mixed or contacted with a chromogenic substrate effective to produce a colored product upon reaction with xcex1-amylase present in the sample.
U.S. Pat. No. 5,736,322 to Goldstein describes a substitute oral fluid standard for testing, calibration, and standardization of devices and methods for collection, storage, and analysis or oral fluids. The oral fluid standard comprises a mucin and protease inhibitor.
U.S. Pat. No. 5,705,353 to Oh et al describes an assay for determining the presence of an analyte of interest in a test sample containing an interfering substance that interferes with the assay is disclosed. The assay comprises the steps of forming a reaction mixture by combining in an assay medium (i) an assay system containing components for detecting the analyte of interest, (ii) a test sample containing the analyte and an interfering substance, and (iii) an additional amount of the interfering substance in a quantity sufficient to substantially mask the effect of the interfering substance in the test sample.
U.S. Pat. No. 5,871,905 to Thieme et al describes the use and composition of materials which, when added to oral fluid samples, make such sample suitable for use with microparticle-based immunoassays. The method involves providing an oral fluid sample combined with a bile acid or salt to reduce the rate of occurrence of false positives in said oral fluid based immunoassays.
U.S. Pat. No. 3,915,639 to Friedenberg describes a drug abuse compounds that are quantitatively and semi-quantitatively detected by the use of an ion exchange dipstick in combination with a stain-producing reagent, and a stain-intensifying reagent which will intensify the coloring effect of the stain-producing reagent.
U.S. Pat. No. 4,231,923 to Miller et al describes an assay method for opioid activity comprising the steps of (a) incubating together an opiate receptor material, a radio-iodinated structural analogue of leucine-enkephalin or methionine-eukephalin, and a liquid sample; (b) measuring the percentage inhibition of the binding of the radio-iodinated compound to the opiate receptor material; and (c) determining the opioid activity of the liquid sample using the percentage inhibition measurement.
U.S. Pat. No. 4,997,771 to Barnett et al describes a method for determining the BZ-1 receptor activity of a test sample or a potential anxiolytic drug.
U.S. Pat. No. 5,073,340 to Covington et al describes a test device for use in determining analyte wherein binder is supported on a solid support in admixture with a marker whereby the presence and location of binder on the support can be determined prior to the assay.
U.S. Pat. No. 5,075,078 to Osikowicz et al describes an improved chromatographic strip binding assay devices provided for determining the presence or amount of an analyte present in a patient sample.
U.S. Pat. No. 5,079,141 to Niskanen et al describes an invention that comprises a pre-filled and pre-sealed apparatus for carrying out chemical, particularly immuno-chemical, analyses in non-laboratory environments.
U.S. Pat. No. 5,101,015 to Brynes et al describes a fluorescence polarization immunoassay (FPIA) for detecting the presence of one or more amphetamine-class analytes in a test sample.
U.S. Pat. No. 5,140,161 to Hillman et al describes methods and devices involving at least one chamber, at least one capillary, and at least one reagent involved in a system providing for a detectable signal.
U.S. Pat. No. 5,238,652 to Sun et al describes an analytical test device for competition assay for particular non-protein antigens, such as antigens representing drugs of abuse.
U.S. Pat. No. 5,244,815 to Guirguis describes a method and device for testing for the presence of substances such as drugs in body fluids while simultaneously positively identifying the test substance.
U.S. Pat. No. 5,304,479 to Lin et al describes a derivatives of phencyclidine provided as precursors for conjugating to antigenic proteins for the preparation of antibodies which bind to phencyclidine or conjugation to enzymes for use as reagents in immunoassays.
U.S. Pat. No. 5,583,003 to Hillyard et al relates to a reagent and a method for detecting an antigen, antibody or other analyte in a sample, such as human or animal blood, by an agglutination assay.
U.S. Pat. No. 5,022,409 to Goldstein et al describes an invention concerning the collection of immunoglobulins from the oral cavity for immunological testing.
U.S. Pat. No. 5,260,031 to Seymour describes a saliva sampling device includes a holder, a saliva collector and an indicator.
U.S. Pat. No. 5,334,502 to Sangha describes a method for rapidly determining during a saliva specimen collection procedure the presence of an amount of saliva, and for verifying that the sample obtained is in fact saliva.
U.S. Pat. No. 5,968,746 to Schneider describes a method and apparatus for the preservation of a saliva sample for use in subsequent quantitative chemical assays.
U.S. Pat. No. 6,022,326 to Tatum et al describes a method and device for automatic or semi-automatic collection of saliva has a mouthpiece on a wand.
U.S. Pat. No. 4,774,192 to Terminiello et al describes a dry chemistry reagent system, kit and method for detection of an analyte such as glucose, cholesterol, urea, antigen or antibody.
U.S. Pat. No. 5,260,194 to Olson describes a method and device for determining the presence of analyte in a sample suspected of containing the analyte.
U.S. Pat. No. 5,656,448 to Kang et al describes an invention pertains to dipstick immunoassay devices.
U.S. Pat. No. 4,843,377 to Fuller et al describes a remote confinement or home arrest system and method which provides for determining from a central office the presence of a prisoner at an assigned remote location such as the prisoner""s home and for determining the compliance by the prisoner with behavioral restrictions associated with the confinement such as the abstinence from alcohol or other drugs.
U.S. Pat. No. 4,844,866to Wallace et al describes a carrier for detecting drug abuse compounds which changes color upon contact with such compounds.
U.S. Pat. No. 5,817,011 to Schoendorfer describes a dermal patch to be worn on the skin for increasing the concentration of an analyte expressed through the skin in perspiration to a conveniently measurable level.
U.S. Pat. No. 5,955,377 to Maul et al describes devices that produce detectable attenuation of the spectral characteristic of light impinging on the device by thin film phenomenon.
U.S. Pat. No. 5,103,836 to Goldstein et al describes a method and device for collecting immunoglobulins and other analytes from the oral cavity for immunological and other testing.
U.S. Pat. No. 5,234,001 to Goldstein et al describes a container for storing collected substances for subsequent testing having an open upper end adapted to be sealed with a removable stopper and a lower end having an opening communicating the interior of the container with the outside.
U.S. Pat. No. 5,335,673 to Goldstein et al describes a method and device for collecting immunoglobulins and other analytes from the oral cavity for immunological and other testing.
In all cases, the normal procedure followed when performing diagnostic test is to collect the sample using either a collection container (for urine or other liquid), a syringe/collection tube (for blood) or some type of collection swab (for saliva, sweat, biological substances or environmental substances). Problems arise when the subject/source can only provide a minimal amount of sample, either because of normal biological restrictions or other reasons. This problem of minimal sample is particularly well documented when the sample to be tested is saliva or sweat. As such, there were generally two possible solutions. One was to collect the sample (i.e. saliva) using an absorbent material and then attempt to xe2x80x9cwashxe2x80x9d sample off the collection pad in a separate vial containing a buffer/saline solution. The liquid buffer presumably contains the xe2x80x9csamplexe2x80x9d and is transferred to the test/diagnostic kit either by pouring or pipetting. The second solution would be to collect the sample using an absorbent collection material and then attempt to xe2x80x9csqueezexe2x80x9d the sample off the pad and xe2x80x9cdropxe2x80x9d it directly onto the test device. In all cases, two separate devices and multiple steps are required to perform the test. Additionally, other problems exist, including: sample being contaminated by contact with collector/operator; insufficient xe2x80x9cwashingxe2x80x9d resulting in insufficient sample; exposure to the sample collection material as you try to squeeze if off the pad; and multiple steps leading to operator error in test performance.
Accordingly, it is an object of the present invention to provide a xe2x80x9cone-devicexe2x80x9d system to collect, transfer, extract, test and retain a portion of the sample to confirm for various constituents in fluids.
It is another object of the present invention to provide a xe2x80x9cone-devicexe2x80x9d system to collect, transfer, extract, test and retain a portion of the sample to confirm for various constituents in fluids with a super absorbent materials for maximum sample collection, wherein the super-absorbent material is selected from a group, comprising gel, foam, fiber glass, cotton, cellulose, rayon and other synthetic materials.
It is another object of the present invention to provide a xe2x80x9cone-devicexe2x80x9d system to collect, transfer, extract, test and retain a portion of the sample to confirm for various constituents in fluids with micro-sample pores for samples to be directly extracted from collection material and transferred to the detection indicator for diagnostic testing.
It is another object of the present invention to provide a xe2x80x9cone-devicexe2x80x9d system to collect, transfer, extract, test and retain a portion of the sample to confirm for various constituents in fluids with a set of pressure heads pressing the sample from the collection end into the micro-pores then onto the detection indicator for testing.
It is another object of the present invention to provide a xe2x80x9cone-devicexe2x80x9d system to collect, transfer, extract, test and retain a portion of the sample to confirm for various constituents in fluids with a series of micro-channels into which the micro-pores are directing the sample to flow through onto the detection indicator for testing.
It is another object of the present invention to provide a xe2x80x9cone-devicexe2x80x9d system to collect, transfer, extract, test and retain a portion of the sample to confirm for various constituents in fluids with sealing fins to which once fluid enters into the fins, the fins will prevent the fluid from leaking out of the system.
It is another object of the present invention to provide a xe2x80x9cone-devicexe2x80x9d system to collect, transfer, extract, test and retain a portion of the sample to confirm for various constituents in fluids with a sample retention well, sealed from the outside allowing samples to be sent later to a laboratory for testing.
It is another object of the present invention to provide a xe2x80x9cone-devicexe2x80x9d system to collect, transfer, extract, test and retain a portion of the sample to confirm for drugs of abuse in bodily fluids wherein the fluid is selected from a group comprising saliva, sweat, urine, blood and other bodily fluids.
It is another object of the present invention to provide a xe2x80x9cone-devicexe2x80x9d system to collect, transfer, extract, test and retain a portion of the sample to confirm for drugs of abuse in bodily fluids with a super absorbent material for maximum sample collection, wherein the super-absorbent material is selected from a group comprising gel, foam, fiber glass, cotton, cellulose, rayon and other synthetic materials.
It is another object of the present invention to provide a xe2x80x9cone-devicexe2x80x9d system to collect, transfer, extract, test and retain a portion of the sample to confirm for drugs of abuse in bodily fluids with micro-sample pores for samples to be directly extracted from collection material and transferred to the strips for diagnostic testing.
It is another object of the present invention to provide a xe2x80x9cone-devicexe2x80x9d system to collect, transfer, extract, test and retain a portion of the sample to confirm for drugs of abuse in bodily fluids with a set of pressure heads pressing the sample from the collection and into the micro pores, then onto immunoassay strips for testing.
It is another object of the present invention to provide a xe2x80x9cone-devicexe2x80x9d system to collect, transfer, extract, test and retain a portion of the sample to confirm for drugs of abuse in bodily fluids with a series of micro-channels into which the micro-pores directing the sample to flow through onto the testing strips.
It is another object of the present invention to provide a xe2x80x9cone-devicexe2x80x9d system to collect, transfer, extract, test and retain a portion of the sample to confirm for various constituents in fluids with a cassette containing chemical strips, to provide an indication of a characteristics of the fluids regarding drugs of abuse, as a detection indicator.
It is another object of the present invention to provide a xe2x80x9cone-devicexe2x80x9d to collect, transfer, extract, test and retain a portion of the sample to confirm for various constituents in fluids with chemical strips used to test for THC, COC, MOR, AMP, BZO, PCP, BAR, MET and OPI, etc. in the fluids.
It is another object of the present invention to provide a xe2x80x9cone-devicexe2x80x9d system to collect, transfer, extract, test and retain a portion of the sample to confirm for various constituents in fluids with constituents in fluids wherein the system further comprising sealing fins to which once fluid enters into the fins, the fins will prevent the fluid from leaking out of the system.
It is another object of the present invention to provide a xe2x80x9cone-devicexe2x80x9d system to collect, transfer, extract, test and retain a portion of the sample to confirm for drugs of abuse in bodily fluids with a sample retention w ell sealed from the outside allowing samples to be sent later to a laboratory for testing.
Other objectives and advantages of the invention will become apparent from the following detailed disclosure.